ClinicalTrials.gg
CompletedNCT06972992Updated Dec 18, 2025

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide

A Phase 1 interventional study of ASC47 +Semaglutide and Placebo+Semaglutide in Chronic Weight Management, sponsored by Ascletis Pharma (China) Co., Limited. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by Ascletis Pharma (China) Co., Limited (part of Ascletis Pharma Inc.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2025, 1 year 1 month ago, and no results have been posted to the registry.

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Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.

02

Conditions studied

  • Chronic Weight Management
03

In context

Lead sponsor

Ascletis Pharma (China) Co., Limited is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject have provided before initiation of any study specific procedures
  • Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective measures from the first dose of the product until 3 months after the last dose are eligible.
  • No findings from medical history, physical examination, 12-lead , vital signs measurements, and other screening procedures, e.g., Clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia as assessed by the Investigator (or sub-I).
  • Stable body weight (less than 5% self-reported change within the previous 3 months)

Exclusion criteria

Exclusion Criteria:

  • Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
  • Have a history of active or untreated or are in remission from a malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
  • Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year.
  • Have an disease, is or is in any way immunocompromised.
  • Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 half-lives of the experimental agent (exception of placebo) prior to the start of the treatment.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Combo Cohort 1 in participants with obesity

    Cohort 1, dose 1

    Drug: ASC47 +Semaglutide · Drug: Placebo+Semaglutide

  • Experimental
    Combo Cohort 2 in participants with obesity

    Cohort 2, dose 2

    Drug: ASC47 +Semaglutide · Drug: Placebo+Semaglutide

  • Experimental
    Combo Cohort 3 in participants with obesity

    Cohort 3, dose 3

    Drug: ASC47 +Semaglutide · Drug: Placebo+Semaglutide

Interventions

  • DrugASC47 +Semaglutide

    Drug page: Semaglutide

    ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks

  • DrugPlacebo+Semaglutide

    Placebo single subcutaneous injection + Semaglutide QW for 4 weeks

06

What researchers measure

Primary outcomes

  1. Adverse events

    Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)

    Time frame: up to 71 days

Secondary outcomes

  1. Change From Baseline in Body Weight

    Change from baseline (week 1) to week 10 in body weight was evaluated

    Time frame: up to 71 days

  2. Cmax of ASC47

    Evaluate the Peak Plasma Concentration of ASC47 in combination with semaglutide.

    Time frame: up to 71 days

  3. AUC of ASC47

    Evaluate the Area under the plasma concentration versus time curve of ASC47 in combination with semaglutide.

    Time frame: up to 71 days

  4. T1/2 of ASC47

    Evaluate the Terminal-Phase Half-Life of ASC47 in combination with semaglutide.

    Time frame: up to 71 days

  5. CL/F of ASC47

    Evaluate the Apparent Systemic Clearance of ASC47 in combination with semaglutide.

    Time frame: up to 71 days

07

Study locations

1 site
  • Ascletis Clinical Site
    San Antonio, Texas 78209, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2025 to primary completion in Sep 2025, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2025
First posted
May 15, 2025
StartActual
Apr 18, 2025
Primary completionActual
Sep 22, 2025
CompletionActual
Sep 22, 2025
Last update
Dec 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06972992
Responsible party
Sponsor
First posted
May 15, 2025
Start date
Apr 18, 2025
Primary completion
Sep 22, 2025
Completion
Sep 22, 2025
Last update
Dec 18, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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